qfix AirDrive Caddie RT-5100-S User Manual

PRODUCT GUIDE
& USER MANUAL
RT-5100-S AirDrive Caddie™
Advena Limited
Tower Business Centre, 2nd Flr
Tower Street, Swatar, BKR 4013
Malta
Made in the USA by
Qfix
440 Church Rd,
Avondale, Pennsylvania, USA
+1 484-720-6053 www.Qfix.com
GENERAL PRECAUTIONS
WARNING STATEMENTS
! WARNING ! No modification of this equipment is allowed. If any part of this device
experiences a catastrophic load, appears damaged or functions improperly, discontinue
use immediately and contact Qfix at +1 484-720-6053 or tech support@qfix.com.
! WARNING ! Follow your local regulations for disposal for the AirDrive Caddie and it's
components.
SERIOUS INCIDENTS
Please report any serious incidents (e.g. incidents which result in or have the potential to
result in death or serious injury) to both Qfix and your country's Competent Authority.
SAFETY INFORMATION
The air source should never be operated when loading or unloading a patient on
AirShuttle device.
ENVIRONMENTAL CONDITIONS
Operating
• Temperature: 10°C to 35°C (50°F to 95°F)
• Humidity: 10% to 90% non-condensing
• Atmospheric: 700–1060 hPa
Storage
• Temperature: 0°C to 50°C (32°F to 122°F)
• Humidity: 0% to 95%
• Atmospheric: 700–1060 hPa
Shipping
• Temperature: -29°C to 60°C (-20°F to 140°F)
• Humidity: 0% to 95%
• Atmospheric: 700–1060 hPa
MRI SAFETY INFORMATION
Non-clinical testing has demonstrated the AirDrive Caddie is MR Conditional. This
device may be used with an MR system only under the following conditions:
• Static magnetic field of 3T or less.
• The GaussAlert™ module is installed and operational on the AirDrive Caddie.
• Both the AirShuttle device and the underlying patient support (e.g. trolley, stretcher,
table) is MR Conditional or MR Safe for the MR environment.
• The AirDrive Caddie shall not be moved closer to the MR system than the 30 Gauss
boundary. Identify the 30 Gauss boundary prior to bringing the AirDrive Caddie into
the MR environment.
• The user does not lift the AirDrive Caddie off the floor of the MR room.
• The patient support is in a braked or otherwise fixed condition prior to patient
transfers taking place.
Non-clinical testing has demonstrated the AirShuttle Transfer Handles are MR
Conditional. These devices may be used with an MR system meeting the following
conditions:
• Static magnetic field of 3T or less.
• The AirShuttle Transfer Handles must be removed from the device prior to placing
the device into the bore of the MR system.
Qfix | 440 Church Road | Avondale, Pennsylvania 19311 USA |
UK Responsible Person
QServe Group UK, Ltd.
49 Greek Street
Soho, London W1D 4EG
United Kingdom
Raditec Medical AG
Schlossberg 5a
5454 Bellikon
Switzerland
2008502_EN_C / 2024-01
PRODUCT GUIDE AND USER MANUAL – 2008502, AirDrive Caddie_EN
Non-clinical testing has demonstrated the AirDrive Charging Cable is MR Conditional.
This device may be used with an MR system meeting the following conditions:
• Static magnetic field of 3T or less.
• The AirDrive Caddie must not be on charge in the MRI room when imaging. Doing
so could result in MR image artifacts.
Non-clinical testing has demonstrated the AirDrive Pendant Switch is MR Conditional.
This device may be used with an MR system meeting the following conditions:
• Static magnetic field of 3T or less.
Non-clinical testing has demonstrated the AirDrive Pneumatic Foot Switch is
MR Safe. This device may be used in an MR environment.
! WARNING ! Not adhering to the conditions described above when using
AirDrive Caddie and other components of the AirDrive system in the MR environment
may result in injury to the patient or clinician.
! WARNING ! Recommended maintenance and service, as well as use of only
Qfix-provided accessories, components, and replacement parts, are necessary to
ensure the safety, performance, and MRI compatibility of the product(s), as well as to
maintain applicable warranties.
! WARNING ! Use of unapproved MR accessories may result in:
• Injury to patient
• Patient burns
• Damage to equipment
Use only proven MR Safe or MR Conditional accessories, tested and approved for your
MR system.
Consider the MR compatibility of accessories prior to use on your MR system.
! WARNING ! Maintenance and other service of qfix products should never be
performed in an MR environment.
ELECTRONIC EMISSIONS
The AirDrive Caddie is classified as Emissions Class A and has been tested to Immunity
to RF Electromagnet Fields at a level of 3 V/m per IEC 60601-1-2. The AirDrive Caddie
is an electronic device that may interfere with other electronic devices. If the
AirDrive Caddie interferes with other electronic devices, move the AirDrive Caddie away
from affected device(s).
! WARNING ! The AirDrive Caddie may be affected by emissions from nearby electronic
devices, including devices adjacent to or placed on the AirDrive Caddie. Emissions
may affect control of the AirDrive Caddie, rendering them inoperable. In the event that
control of AirDrive Caddie is impaired, separate the AirDrive Caddie and the emitting
devices by a sufficient distance. If electronic devices are to be used on or adjacent to
the AirDrive Caddie, this equipment and the AirDrive Caddie should be observed to
verify that they are operating normally.
! WARNING ! Use of accessories and cables other than those specified or provided by
Qfix could result in increased electromagnetic emission or decreased electromagnetic
immunity of this equipment and result in improper operation.
! WARNING ! Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Airdrive Trolley. Otherwise, degradation of the performance
of the trolley could result.
ADDITIONAL PRECAUTIONS
! CAUTION ! The AirDrive Caddie is electrically powered. To prevent injury, this system's
electronics, internal fuses, and internal battery should be serviced by Qfix-approved
service personnel only.
The use of additional immobilization devices may create additional trapping zones not
described in this Product Guide and User Manual.
Use of the charging cable and the transfer hose may create a tripping hazard. Take care
in managing the charging cable and the transfer hose to avoid potential tripping and
snag scenarios.
When using the AirDrive Caddie, avoid tugging on the hose. Doing so could pull
the hose out of the AirDrive Caddie, cause the AirDrive Caddie to roll, or cause the
AirDrive Caddie to tip over, potentially damaging the device and harming users.
When moving the AirDrive Caddie, take care not to roll over feet or park the
AirDrive Caddie such that it can pinch someone's foot.
Be cognizant of location when parking the AirDrive Caddie or leaving it unattended, as it
may become a trip hazard.
Ensure charging system of AirDrive Caddie is connected to equivalent receptable
marked 'Hospital Only' or ' Hospital Grade'.
! WARNING ! To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
Any tables, stretchers, or other patient supporting surfaces used for the patient transfer
must be fixed, braked, or docked in place prior to patient transfers taking place.
Ensure that the air hose is properly seated in both the AirShuttle device air inlet as well
as the hose connection point in the AirDrive Caddie prior to use of the air source.
! CAUTION ! The AirDrive Caddie is not intended for use in oxygen rich environments or
with flammable agents.
+1 484-720-6053 | +1 610-268-0588 | www.Qfix.com
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